Method and apparatus for treating the brain and/or spinal cord using a catheter

Abstract

A method for treatment of a brain and/or spinal cord includes inserting a flexible catheter into a cerebrospinal fluid space, the flexible catheter including two lumens adapted to allow a fluid to circulate therein in a closed loop within the flexible catheter and the flexible catheter being adapted to be connected to a device for cooling and circulating the fluid. The cerebrospinal fluid in the cerebrospinal fluid space is cooled with the flexible catheter to enable selective central nervous system cooling. The functional status of the brain and/or spinal cord is monitored, and the treatment of the brain and/or spinal cord is modified to adjust for any change in the functional status of the brain and/or spinal cord.

What is claimed is: 
     
       1. A method for treatment of a brain and/or spinal cord, the method comprising:
 inserting a flexible catheter into a cerebrospinal fluid space, the flexible catheter including two lumens adapted to allow a fluid to circulate therein in a closed loop within the flexible catheter and the flexible catheter being adapted to be connected to a device for cooling and circulating the fluid; 
 cooling cerebrospinal fluid in the cerebrospinal fluid space with the flexible catheter to enable selective central nervous system cooling; 
 monitoring a functional status of the brain and/or spinal cord; and 
 modifying the treatment of the brain and/or spinal cord to adjust for any change in the functional status of the brain and/or spinal cord, 
 wherein said cooling of the cerebrospinal fluid comprises cooling the cerebrospinal fluid to a first temperature when the functional status meets a first condition, and cooling the cerebrospinal fluid to a second temperature when the functional status meets a second condition, the second temperature being lower than the first temperature. 
 
     
     
       2. The method of  claim 1 , wherein the flexible catheter has a distal portion that is capable of expansion. 
     
     
       3. The method of  claim 2 , wherein the expansion of the distal end of the flexible catheter comprises one or more of the following: lumen expansion, outer wall expansion, and one or more balloons. 
     
     
       4. The method of  claim 1 , wherein said monitoring of the functional status of the brain and/or spinal cord comprises monitoring one or more of the following: motor evoked potential, somatosensory evoked potential, spinal cord evoked potential, direct wave, nerve evoked potential, central nervous system temperature, pressure, blood flow, blood pressure, perfusion pressure, carbon dioxide pressure, electroencephalography, corticography, brain oxygenation, and cerebrospinal fluid metabolites. 
     
     
       5. The method of  claim 1 , wherein the treatment of the spinal cord is for one or more of the following: trauma, spinal cord injury, ischemia, hypoxia, swelling, aortic aneurysm surgery or endovascular treatment, aortic dissection surgery or endovascular treatment, cross clamping of aorta, tumor, infection, scoliosis surgery, and spine surgery. 
     
     
       6. The method of  claim 1 , wherein the treatment of the brain is for one or more of the following: trauma, ischemia, hypoxia, seizure, hemorrhage, tumor, infection, cranial surgery, increased intracranial pressure, and cerebral swelling. 
     
     
       7. The method of  claim 1 , wherein said modifying of the treatment of the brain and/or spinal cord comprises one or more of the following: adjusting a temperature of the fluid, adjusting intracranial pressure, adjusting spinal intrathecal/cerebrospinal pressure, adjusting blood pressure, adjusting cerebrospinal fluid drainage, adjusting cerebral perfusion pressure, adjusting blood flow, adjusting medication, and performing surgery. 
     
     
       8. The method according to  claim 1 , wherein said cooling of the cerebrospinal fluid further comprises cooling the cerebrospinal fluid to a third temperature when the functional status meets a third condition, the third temperature being lower than the second temperature. 
     
     
       9. A method for treatment of a brain and/or spinal cord, the method comprising:
 providing a flexible catheter including two lumens adapted to allow a fluid to circulate therein in a closed loop within the flexible catheter, and a drainage lumen having one or more ports at a distal end of the flexible catheter which communicate with an environment outside the flexible catheter, the flexible catheter being adapted to be connected to a device for cooling and circulating the fluid; 
 inserting the flexible catheter into a cranium and/or spine to place the distal end of the flexible catheter in a cerebrospinal fluid space; 
 cooling cerebrospinal fluid in the cranium and/or spine with the flexible catheter to enable selective central nervous system cooling; 
 draining cerebrospinal fluid through the drainage lumen in the flexible catheter to decrease pressure in a central nervous system; 
 monitoring a functional status of the brain and/or spinal cord; and 
 modifying the treatment of the brain and/or spinal cord to adjust for any change in the functional status of the brain and/or spinal cord, 
 wherein said cooling of the cerebrospinal fluid comprises cooling the cerebrospinal fluid to a first temperature when the functional status meets a first condition, and cooling the cerebrospinal fluid to a second temperature when the functional status meets a second condition, the second temperature being lower than the first temperature. 
 
     
     
       10. The method of  claim 9 , wherein said flexible catheter has a distal portion that is capable of expansion. 
     
     
       11. The method of  claim 10 , wherein the expansion of the distal end of the flexible catheter comprises one or more of the following: lumen expansion, outer wall expansion, and one or more balloons. 
     
     
       12. The method of  claim 9 , wherein said monitoring of the functional status of the brain and/or spinal cord comprises monitoring one or more of the following: motor evoked potential, somatosensory evoked potential, direct wave, spinal cord stimulation, spinal cord conduction, electromyogram, nerve conduction, nerve stimulation, temperature, pressure, blood flow, blood pressure, perfusion pressure, carbon dioxide pressure, electroencephalography, corticogreaphy, brain oxygenation, and cerebrospinal fluid metabolites. 
     
     
       13. The method of  claim 9 , wherein the treatment of the spinal cord is for one or more of the following: trauma, tumor, hemorrhage, infection, spinal cord injury, increased intracranial/intrathecal pressure, ischemia, hypoxia, spinal cord swelling, aortic aneurysm surgery or endovascular treatment, aortic dissection surgery or endovascular treatment, cross clamping of aorta, scoliosis surgery, and spine surgery. 
     
     
       14. The method of  claim 9 , wherein the treatment of the brain is for one or more of the following: trauma, ischemia, hypoxia, seizure, hemorrhage, tumor, infection, cranial surgery, increased intracranial pressure, and cerebral swelling. 
     
     
       15. The method of  claim 9 , wherein said modifying of the treatment of the brain and/or spinal cord comprises one or more of the following: adjusting a temperature of the fluid, adjusting intracranial pressure, adjusting spinal intrathecal/subdural pressure, adjusting blood pressure, adjusting cerebrospinal fluid drainage, adjusting cerebral perfusion pressure, adjusting blood flow, adjusting medication, and performing surgery. 
     
     
       16. The method according to  claim 9 , wherein said cooling of the cerebrospinal fluid further comprises cooling the cerebrospinal fluid to a third temperature when the functional status meets a third condition, the third temperature being lower than the second temperature. 
     
     
       17. A method for treatment of a brain and/or spinal cord, the method comprising:
 providing a flexible catheter including two lumens adapted to allow a fluid to circulate therein in a closed loop within the flexible catheter, and a drainage lumen having one or more ports at a distal end of the flexible catheter which communicate with an environment outside the flexible catheter, the flexible catheter being adapted to be connected to a device for cooling and circulating the fluid; 
 inserting the flexible catheter into a spine to place the distal end of the flexible catheter in a cerebrospinal fluid space; 
 cooling cerebrospinal fluid in the spine with the flexible catheter to enable selective central nervous system cooling; 
 draining cerebrospinal fluid through the drainage lumen in the flexible catheter to decrease pressure in a central nervous system; 
 monitoring a functional status of the brain and/or spinal cord with brain or spinal cord mediated evoked potentials; and 
 modifying the treatment of the brain and/or spinal cord to adjust for any change in the functional status of the brain and/or spinal cord, 
 wherein said cooling of the cerebrospinal fluid comprises cooling the cerebrospinal fluid to a first temperature when the functional status meets a first condition, and cooling the cerebrospinal fluid to a second temperature when the functional status meets a second condition, the second temperature being lower than the first temperature. 
 
     
     
       18. The method of  claim 17 , wherein said monitoring of the brain or spinal cord mediated evoked potentials comprises monitoring with one or more of the following: motor evoked potential, somatosensory evoked potential, spinal cord evoked potential, direct wave spinal cord stimulation, and antidromic direct wave. 
     
     
       19. The method of  claim 17 , wherein said monitoring of the brain or spinal cord mediated evoked potentials comprises monitoring the functional status of the brain and/or spinal cord with one or more of the following: electromyogram, peripheral or cranial nerve stimulation, nerve conduction, temperature, pressure, blood flow, blood pressure, perfusion pressure, carbon dioxide, electroencephalography, corticogreaphy, brain oxygenation, and cerebrospinal fluid metabolites. 
     
     
       20. The method of  claim 17 , wherein the treatment of the spinal cord is for one or more of the following: trauma, ischemia, hypoxia, swelling, aortic aneurysm surgery or endovascular treatment, aortic dissection surgery or endovascular treatment, cross clamping of aorta, tumor, infection, scoliosis surgery, and spine surgery. 
     
     
       21. The method of  claim 17 , wherein the treatment of the brain is for one or more of the following: trauma, ischemia, hypoxia, seizure, hemorrhage, tumor, infection, cranial surgery, increased intracranial pressure, and cerebral swelling. 
     
     
       22. The method of  claim 17 , wherein said modifying of the brain and/or spinal cord treatment comprises adjusting an extent of selective brain and/or spinal hypothermia. 
     
     
       23. The method of  claim 22 , wherein said adjusting of the extent of selective brain and/or spinal hypothermia comprises adjusting a temperature of the fluid supplied to the flexible catheter from the device for cooling and circulating the fluid. 
     
     
       24. The method of  claim 23 , wherein said adjusting of the temperature of the fluid comprises starting the fluid supplied to the flexible catheter at a first fluid temperature and then gradually decreasing the temperature of the fluid to a second fluid temperature. 
     
     
       25. The method of  claim 22 , wherein said adjusting of the extent of selective brain and/or spinal hypothermia comprises adjusting a flow rate of the fluid supplied to the flexible catheter from the device for cooling and circulating the fluid. 
     
     
       26. The method of  claim 25 , wherein said adjusting of the flow rate of the fluid comprises starting the fluid supplied to the flexible catheter at a first flow rate and then gradually increasing the flow rate of the fluid to a second flow rate. 
     
     
       27. The method of  claim 17 , wherein said modifying of the treatment of the brain and/or spinal cord comprises adjusting an extent of intracranial or spine pressure and cerebrospinal fluid drainage. 
     
     
       28. The method of  claim 27 , wherein said adjusting of the extent of the intracranial or spine pressure comprises adjusting an amount of cerebrospinal fluid drained by said draining of the cerebrospinal fluid. 
     
     
       29. The method of  claim 28 , wherein said adjusting of the amount of cerebrospinal fluid drainage by said drainage of the cerebrospinal fluid comprises using one or more of the following: a valve that opens at a set pressure, an anti-reflux valve, an automated collection chamber that allows fluid drainage at a set pressure, and a drainage bag that allows fluid drainage at a set pressure based on a location of the bag relative to anatomical landmarks. 
     
     
       30. The method according to  claim 17 , wherein said cooling of the cerebrospinal fluid further comprises cooling the cerebrospinal fluid to a third temperature when the functional status meets a third condition, the third temperature being lower than the second temperature.